PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS— 510(k) K964774

Name: FDA 510(k) clearance K964774
Creator: U.S. Food and Drug Administration
Published: 1996-12-20

Substantially Equivalent

Fci Ophthalmics, Inc.

FDA 510(k) clearance K964774 for PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS, Substantially Equivalent on 1996-12-20. Applicant: Fci Ophthalmics, Inc.. Device class: Unclassified.

Clearance details

Applicant: Fci Ophthalmics, Inc.
Product code: Code LZU
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-10-22
Decision date: 1996-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marshfield Hills, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZU

view all

K241229 — Hello,eyes® BIO Plug2024-06-28
K222164 — Visant Medical Canalicular Plug2022-12-23
K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug2022-06-03
K190210 — Tear Pool Dissolvable Punctum Plugs2019-10-24
K162361 — Soft Plug Extended Duration 180 Canalicular Plug2017-04-17

More clearances from Fci Ophthalmics, Inc.

view all

K061404 — MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE2006-08-07
K061398 — SNUG PLUG PUNCTUM PLUG2006-07-11
K041869 — SELF RETAINING BICANALICULUS INTUBATION SET2004-11-18
K023758 — BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)2003-09-17
K023400 — FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT2003-08-22

Adverse events under product code LZU

product code LZU

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.